In an earlier post, I pushed for more emphasis on Covid therapeutics (Covid Therapeutics Take a Back Seat). I mentioned fluvoxamine in a list of promising drugs that should be considered. Today, I want to talk more about this old drug that might be just the right answer for this new pandemic.
Two new oral treatments of Covid were just approved by the FDA last week, Paxlovid and Molnupiravir. Paxlovidhas reduced hospitalizations by about 90% and Molnupiravir has reduced hospitalizations by about 50%. While these drugs are exciting new therapeutic options for Covid treatment, they are currently available in very limited quantities. Pfizer expects to manufacture 180,000 courses by the end of 2021, but that’s far from the needed supply. Molnupiravir may be in even scarcer supply. This means rationing of treatment with these drugs. There are also some concerns Molnupiravir may cause DNA mutations in rare cases.
Fluvoxamine, however, is a pill that has been in widespread usage since 1994 for treatment of obsessive-compulsive disorders. Doctors often prescribe it for other disorders, such as anxiety, depression, and panic attacks, a practice known as “off label” usage. This is quite common in the medical profession as a drug or device is approved for one use, but doctors then find it is also useful for another condition.
Allysia Finley, writing in The Wall Street Journal, tells us studies show that fluvoxamine is highly effective at preventing hospitalization in Covid patients, and it’s unlikely to be blunted by the new Omicron variant. Doctors hypothesize that fluvoxamine can trigger a cascade of reactions in cells that modulate inflammation and interfere with virus functions. It could thus prevent an overreactive immune response to pathogens – a process known as a cytokine storm. Cytokine storms can lead to organ failure and death. Fluvoxamine can also increase nighttime levels of melatonin – the hormone that makes you sleepy – which evidence suggests can also mitigate inflammation.
What is the clinical evidence that fluvoxamine works? A large study in France during the early months of the pandemic found that Covid-19 patients treated with selective reuptake inhibitors, such as fluvoxamine, were significantly less likely to be intubated or die. A small randomized control trial last year by psychiatrists at the Washington University School of Medicine in St. Louis was a spectacular success: None of the 80 participants who started fluvoxamine within seven days of developing symptoms deteriorated. However, 6 of the 72 patients in the control group got worse, and four were hospitalized. These results were published in November, 2020 in the Journal of the American Medical Association (JAMA), inspiring a real-world experiment.
Soon after the study was published, there was a Covid outbreak among employees at the Golden Gate Fields horse racing track in Berkeley, California. The physician at the track offered fluvoxamine to the workers. After 14 days, none of the 65 patients who took it were hospitalized or still had symptoms. But of the 48 who didn’t take the drug, 6 (12.5%) were hospitalized and one died. Twenty-nine had lingering symptoms, which might have resulted from inflammatory damage to their organs.
Other studies have had similar dramatic results. Researchers at McMaster University in Hamilton, Ontario, last winter launched a large clinical trial in Brazil. The results from their trial were published in the Lancet medical journal in October. Fluvoxamine reduced the odds of hospitalization or emergency care by 66% and death by 90% among unvaccinated high-risk patients who mostly followed the treatment regimen – compared to monoclonal antibodies. There was no difference in adverse effects between the fluvoxamine and placebo groups.
Here is the best part – a 10-day course of fluvoxamine costs $4, compared with the $2100 the U.S. government has been paying for monoclonal antibodies, and $530 to $700 for a course of the Pfizer and Merck oral treatments. Multiple drug makers manufacture fluvoxamine and could ramp up supply without much difficulty were demand to increase.
There is no need for the FDA to grant Emergency Use Authorization (EUA) for doctors to prescribe this drug now. However, many doctors may be reluctant to prescribe it without EUA or NIH recommendations. Physicians have been investigated by state medical boards for prescribing other “off label” drugs for Covid, such as ivermectin.
The perfect Covid treatment would have the following characteristics:
- Effective in reducing hospitalizations and death
- Oral treatment available at home
- Proven safety record over many years
- Readily available
- Low cost
Fluvoxamine checks all of these boxes. What’s not to like? It’s time the FDA, CDC, and NIH all realize this may be the drug we have all been waiting for.